KYOCERA MEDICAL TECHNOLOGIES, INC.

Address:1200 California Street,Redlands,CA,92374,US

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Intervertebral Fusion Device With Integrated Fixation, Lumbar (OVD) (10)

Premarket Exempt

No Yes

Clear

Kyocera Medical Technologies, Inc. - 00841523100118 Catalog Number : 1031-302-612

Device Description : Ti-6Al-4V ALIF Implant 30 x 26, 12mm 7° Lordosis

Device Class : 2

Duns Number: 116995646

Premarket Exempt : No

Product Code : OVD

Prescription Use : Yes

Device Count : 1

Kyocera Medical Technologies, Inc. - 00841523100125 Catalog Number : 1031-302-613

Device Description : Ti-6Al-4V ALIF Implant 30 x 26, 13mm 7° Lordosis

Device Class : 2

Duns Number: 116995646

Premarket Exempt : No

Product Code : OVD

Prescription Use : Yes

Device Count : 1

Kyocera Medical Technologies, Inc. - 00841523100132 Catalog Number : 1031-302-614

Device Description : Ti-6Al-4V ALIF Implant 30 x 26, 14mm 7° Lordosis

Device Class : 2

Duns Number: 116995646

Premarket Exempt : No

Product Code : OVD

Prescription Use : Yes

Device Count : 1

Kyocera Medical Technologies, Inc. - 00841523100149 Catalog Number : 1031-302-615

Device Description : Ti-6Al-4V ALIF Implant 30 x 26, 15mm 7° Lordosis

Device Class : 2

Duns Number: 116995646

Premarket Exempt : No

Product Code : OVD

Prescription Use : Yes

Device Count : 1

Kyocera Medical Technologies, Inc. - 00841523100156 Catalog Number : 1031-302-616

Device Description : Ti-6Al-4V ALIF Implant 30 x 26, 16mm 7° Lordosis

Device Class : 2

Duns Number: 116995646

Premarket Exempt : No

Product Code : OVD

Prescription Use : Yes

Device Count : 1

Kyocera Medical Technologies, Inc. - 00841523100163 Catalog Number : 1031-302-617

Device Description : Ti-6Al-4V ALIF Implant 30 x 26, 17mm 7° Lordosis

Device Class : 2

Duns Number: 116995646

Premarket Exempt : No

Product Code : OVD

Prescription Use : Yes

Device Count : 1

Kyocera Medical Technologies, Inc. - 00841523100170 Catalog Number : 1031-302-618

Device Description : Ti-6Al-4V ALIF Implant 30 x 26, 18mm 7° Lordosis

Device Class : 2

Duns Number: 116995646

Premarket Exempt : No

Product Code : OVD

Prescription Use : Yes

Device Count : 1

Kyocera Medical Technologies, Inc. - 00841523100187 Catalog Number : 1031-302-619

Device Description : Ti-6Al-4V ALIF Implant 30 x 26, 19mm 7° Lordosis

Device Class : 2

Duns Number: 116995646

Premarket Exempt : No

Product Code : OVD

Prescription Use : Yes

Device Count : 1

Kyocera Medical Technologies, Inc. - 00841523100194 Catalog Number : 1031-302-620

Device Description : Ti-6Al-4V ALIF Implant 30 x 26, 20mm 7° Lordosis

Device Class : 2

Duns Number: 116995646

Premarket Exempt : No

Product Code : OVD

Prescription Use : Yes

Device Count : 1

Kyocera Medical Technologies, Inc. - 00841523100200 Catalog Number : 1031-302-621

Device Description : Ti-6Al-4V ALIF Implant 30 x 26, 21mm 7° Lordosis

Device Class : 2

Duns Number: 116995646

Premarket Exempt : No

Product Code : OVD

Prescription Use : Yes

Device Count : 1

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